Tampon packaging system

ABSTRACT

Absorptive pads including catamenial tampons are provided which are characterized by O 2  levels sufficiently reduced so as to reduce the introduction of air into the vaginal canal with a resulting reduction in the probability of production of toxic shock syndrome exotoxin during internal use of the pads.

This is a divisional of U.S. patent application Ser. No. 08/818,919,filed on Mar. 17, 1997 now U.S. Pat. No. 5,817,047, issued in the nameof Osborn III, et al. on Oct. 6, 1998.

BACKGROUND OF THE INVENTION

The invention relates generally to absorptive pads for internal useincluding surgical and wound dressings and packings, and surgicalsponges and more specifically to catamenial tampons. The inventionfurther relates to such absorptive pads intended to reduce theintroduction of air into the vaginal canal with a resulting reduction inthe probability of production of toxic shock syndrome exotoxin as aresult of insertion of such pads and methods for production of suchpads.

Toxic shock syndrome is a syndrome with a high mortality ratecharacterized by rapid onset of high fever, vomiting, diarrhea and rashfollowed by a rapid drop in blood pressure and vital organ failure.Toxic shock syndrome is associated with the presence of Staphylococcusaureus bacteria and one or more exotoxins which are produced by thebacteria. The exotoxins associated with toxic shock syndrome includeExotoxin A, B, and C, Pyrogenic Exotoxin C, Enterotoxin A, EnterotoxinB, Enterotoxin C, Staphylococcal Enterotoxin F and Toxic Shock Syndrometoxin-1. Toxic shock syndrome is not caused by the bacteria per se butrather by the toxic effects of the associated exotoxin which can passfrom the vagina and other internal body cavities into the bloodstream.

Toxic shock syndrome has been found to be associated with the use ofabsorptive pads within the vagina which may promote the growth ofbacteria and the production of exotoxin in their vicinity. The syndromehas been observed with surgical dressings but appears to be particularlyassociated with the use of catamenial tampons. The syndrome appears tooccur with elevated frequency in association with those absorptive padswhich are characterized by high levels of absorbency and whichaccordingly are left inside the body for extended periods. Of interestto the present invention is the observation of Robbins et al., J. Clin.Microbiol., 25, 1446-1449 (1987) that the main role of tampons in toxicshock syndrome may be that of providing a fibrous surface for heavycolonization and sufficient air for toxin production. Lee et al., J.Clin. Microbiol., 25, 87-90 (1987) suggest that elevated levels of CO₂promote toxin production.

While a preferred approach for reducing the risk of toxic shock syndromewhen using absorptive pads is to frequently exchange new pads for usedones, various other approaches have been proposed by the art forreducing the risk of toxic shock syndrome associated with an internalabsorbent pad. One approach is the incorporation of antibiotics or otherbactericides into the absorbent pad such as described in Leveen et al.,U.S. Pat. No. 5,000,749 and U.S. Pat. No. 5,070,889 which describe useof iodine bactericides in tampons and catamenial sponges. Such anapproach is not always suitable for use in a catamenial product,however, because a bactericide which is active against Staphylococcusaureus can adversely affect other beneficial bacteria which make up thevaginal flora. In a related method, Lefren et al., U.S. Pat. No.4,431,427 describes the use of catamenial tampons comprising substancessuch as organic acids which will maintain a pH of about 4.5 to 2.5 inthe fluids absorbed during use of the tampons such that the growth ofpathogenic bacteria is inhibited.

Other approaches are directed to inactivation of the toxic shocksyndrome exotoxin. Jacob et al., U.S. Pat. No. 4,585,792; U.S. Pat. No.4,722,936; and U.S. Pat. No. 4,722,937 describe the administration ofL-ascorbic acid for the detoxification of the Staphylococcus aureustoxins Pyrogenic Exotoxin C and Staphylococcal Enterotoxin F. WhileJacob et al. do not ascribe a mechanism for the effectiveness ofascorbic acid at neutralizing toxic shock syndrome exotoxin they observethat L-ascorbic acid is known to be a reducing agent and stronganti-oxidant and that it might operate to inactivate bacterial toxins byreducing disulfide bonds within the toxins.

Another approach is directed to the incorporation of substances withinan absorbent pad which inhibit the production of toxic shock syndromeexotoxins by Staphylococcus aureus. Kass, U.S. Pat. No. 4,769,021describes the incorporation of non-toxic divalent magnesium cations inabsorptive pads in order to reduce the concentrations of availablemagnesium ions below those critical for optimal production of toxicshock syndrome toxin-1 and other staphylococcus products.

Of interest to the present invention are conventional tampons andinserters of various designs including those disclosed by U.S. Pat. No.3,902,493 to Baier, et al.; U.S. Pat. No. 4,077,409 to Murray, et al.;U.S. Pat. No. 4,286,596 to Rubinstein; U.S. Pat. No. 4,413,986 toJacobs; U.S. Pat. No. 4,431,427 to Lefren et al.; U.S. Pat. No.4,447,222 to Sartinoranont; and U.S. Pat. No. 4,486,191 to Jacob.

Despite these developments there remains a desire in the art forabsorbent pads suitable for internal use, including catamenial tampons,which are characterized by reduced risk of toxic shock syndrome.

SUMMARY OF THE INVENTION

The present invention provides improved catamenial tampons, wherein thetampons are intended to inhibit the increased production of toxic shocksyndrome exotoxin during their use. Also provided are methods forproduction of such tampons.

The present invention relates to the observation that while toxic shocksyndrome exotoxin is produced at low levels under the anaerobicconditions which normally exist in the vagina, its production is greatlyincreased under aerobic conditions (i.e., in the presence of molecularoxygen, O₂). It has further been observed that the presence of carbondioxide (CO₂) promotes the production of toxic shock syndrome exotoxin.Because absorbent pads including catamenial tampons contain in theirinterstices large amounts of air including O₂ and CO₂, the use of thosepads in normally anaerobic environments such as the vagina can promotethe production of toxic shock syndrome exotoxin.

The present invention provides a combination catamenial tampon andinserter characterized by having an O₂ level sufficiently reduced so asto reduce the introduction of O₂ into the vaginal canal with a resultingreduction in the probability of production of toxic shock syndromeexotoxin during internal use of the tampon. According to preferredembodiments, the amount of O₂ present in the catamenial tampon should beless than 2×10⁻⁴ moles and preferably less than 1×10⁻⁵ moles. Accordingto preferred embodiments, the O₂ partial pressure in the vagina about 90minutes after tampon insertion is less than about 50 mm Hg.

According to one embodiment of the invention, the O₂ (and CO₂) normallypresent in the pad is replaced with a biocompatible gas that does notpromote production of toxic shock syndrome exotoxin. Such gases include,but are not limited to, nitrogen (N₂), neon, argon, helium, fluorinatedhydrocarbons, and other suitable biocompatible gases having a vaporpressure of greater than 1 atmosphere at 0° C. According to anotherembodiment, the absorptive pad is physically sealed in a manner whichprevents O₂, and CO₂ infiltration into the pad. Preferably, the tamponis sealed under a positive head pressure with a biocompatible gas whichdoes not promote production of toxic shock syndrome exotoxin such thatO₂ and CO₂ will not be introduced into the vagina during insertion ofthe tampon.

According to another embodiment, the pad and/or inserter can alsocomprise O₂ and/or CO₂ scavengers. According to yet another embodiment,the CO₂ level in the catamenial tampon is sufficiently reduced as to beeffective in reducing the production of toxic shock syndrome exotoxin.The amount of CO₂ present in the catamenial tampon should be less than3.1×10⁻⁷ moles and preferably less than 1.6×10⁻⁸ moles.

The invention further provides methods for producing the combinationtampon and inserter comprising a catamenial tampon characterized byhaving an O₂ level sufficiently reduced as to be effective in reducingthe production of toxic shock syndrome exotoxin during internal use ofthe tampon, and an inserter enclosing the tampon and reducingcontamination of the tampon with environmental O₂ during storagecomprising the steps of (1) producing a catamenial tampon, (2) removingO₂ present in the tampon, and (3) sealing the tampon with the inserterenclosing the tampon. An alternative method comprises the steps of (1)producing a catamenial tampon, (2) providing an inserter, (3) placingthe tampon in the inserter, (4) removing O₂ present in the inserter, (5)removing O₂ present in the tampon, and (6) sealing the tampon with theinserter enclosing the tampon. While the tampon could be sealed in theinserter under a vacuum it is preferred that the O₂ present in thetampon (and in the inserter) be replaced with a biocompatible gas whichdoes not promote production of toxic shock syndrome, preferred gasesincluding N₂, neon, argon, helium, and a fluorinated hydrocarbon havinga vapor pressure of greater than 1 atmosphere at 0° C.

A further alternative method of producing the combination tampon andinserter comprises the steps of (1) producing a catamenial tampon undersubstantially O₂ -free conditions, (2) providing an inserter, and (3)sealing the tampon with the inserter enclosing the tampon. Preferably,the tampon is produced in the presence of a biocompatible gas which doesnot promote the production of toxic shock syndrome, most preferably amember selected from the group consisting of N₂, neon, argon, helium,and fluorinated hydrocarbons having a vapor pressure of greater than 1atmosphere at 0° C. The step of sealing the tampon with the inserterenclosing the tampon is preferably carried out in the presence of thebiocompatible gas which may then be enclosed in the inserter at anelevated positive pressure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional side elevational view of a catamenial tamponand inserter in accordance with the present invention;

FIG. 2 is a cross-sectional side elevational view of a catamenial tamponand inserter having a bellows device in accordance with the presentinvention; and

FIG. 3 is a cross-sectional side elevational view of a catamenial tamponand inserter having a gas-containing vessel.

DETAILED DESCRIPTION

The present invention is directed to improved absorptive pads forinternal use including catamenial tampons, wherein the pads are intendedto inhibit the increased production of toxic shock syndrome (TSS)exotoxin during their use. Also provided are methods for production ofsuch pads. The absorptive pads of the invention are characterized byhaving an O₂ level sufficiently reduced as to be effective in reducingthe production of toxic shock syndrome exotoxin during internal use ofthe tampon.

The physical features of this invention are referenced by FIG. 1. Thecombination tampon and inserter 10 is constructed with three differentitems: a tampon 20, an insertion means such as a plunger 30, and asealed cylinder 50. The inserter comprises the plunger 30 and the sealedcylinder 50. The tampon 20 is disposed in the sealed cylinder 50 and isenclosed by the inserter.

The tampon 20 is intended to reduce the introduction of air into thevaginal canal with a resulting reduction in the probability ofproduction of toxic shock syndrome exotoxin during internal use of suchpads. A string 80 extends from the tampon 20 and preferably is retainedin the rear portion of the plunger 30 to prevent the string 80 fromacting as a channel for air from the surroundings to enter the plunger30. Insertion of the tampon 20 is accomplished by pushing a grippingmeans 70 or the rear end of the plunger 30 towards a gripping means 60or rear end of the sealed cylinder 50. The forward end or end of thesealed cylinder 50 distal to the plunger 30 will then rupture uponinsertion to allow the tampon 20 to enter the user's vagina.

According to one embodiment of the invention, the inserter includes theplunger 30 at the rear end of the sealed cylinder 50. As seen in FIG. 2,the plunger 30 may include a bellows device 100 attached to orintegrally sealed with the sealed cylinder 50. The bellows device 100maintains a seal as a user presses the plunger 30 inwardly toward thesealed cylinder 50. The bellows device 100 may contain a pressurizedbiocompatible gas to inhibit O₂ and CO₂ from migrating from the bellowsdevice 100 into the sealed cylinder 50. In such an embodiment, thebellows device 100 reduces the replacement of biocompatible gas by O₂during storage and insertion. The bellows device 100 preferably has apermeation coefficient for nitrogen of less than about 3×10⁻⁹ (cm³mm)/(sec cm² cm Hg) and a permeation coefficient for oxygen less thanabout 1.5×10⁻⁹ (cm³ mm)/(sec cm² cm Hg). (ASTM standard method D 1434-82is suitable for measuring permeation coefficients.)

Additionally or alternatively to the bellows device 100, the insertermay include a gasket or O-ring 110 to seal the interface between theplunger 30 and the sealed cylinder 50. As an alternative to the bellowsdevice 100, the O-ring 110 is a less bulky means for sealing theinserter. However, as mentioned above, the bellows device 100 can befilled with a pressurized biocompatible gas if desired. Preferably, acombination of the bellows device 100 and the O-ring 110 is used to sealthe inserter.

Preferably, the sealed cylinder 50 is between about 5.5 and 8.5 cm inlength and has an outer diameter of about 1.0 to 1.6 cm. The plunger 30preferably has an outer diameter of about 0.6 to 1.4 cm and a length ofabout 6.0 to 8.1 cm. The overall length of the inserter, including theplunger 30 and the sealed cylinder 5O, is preferably about 10.0 to 14 cmprior to tampon insertion. Although described above as cylindrical, thecross-sectional shape of the inserter, including the sealed cylinder 50and the plunger 30, may be of any convenient form. It is alsoappropriate to make the inserter from an inexpensive plastic material.Suitable materials for forming the inserter include polymers that can beinjection molded or blow molded. Alternatively, the inserter could beformed from a sufficiently stiff laminate that is rolled to form acylinder, side seamed, with a tip being joined to one end of thecylinder. As discussed below, materials having particular permeationcoefficients are preferred for inserters of some embodiments. The volumeof the tampon inserter is between about 5 and 15 ml., preferably betweenabout 6 and 12 ml.

An outwardly projecting member may be attached to the sealed cylinder 50between the gripping means 60 and the forward end of the sealed cylinder50. The outwardly projecting member provides a convenient means forpositioning the sealed cylinder 50 by engaging the labia and preventingthe forward end of the sealed cylinder 50 from being inserted too farinto the vagina.

During insertion of the tampon 20 into the vagina, the plunger 30 isdepressed into the sealed cylinder 50 which ruptures the end of thesealed cylinder 50 distal to the plunger 30 and introduces the tampon 20into the user's vagina. The tampon and inserter combination 10preferably introduces a biocompatible gas which does not promoteproduction of toxic shock syndrome exotoxin into the vagina. Thebiocompatible gas further inhibits migration of O₂ and CO₂ into thevagina during removal of the inserter. Such gases include, but are notlimited to, nitrogen (N₂), neon, argon, helium, fluorinatedhydrocarbons, and other suitable biocompatible gases having a vaporpressure of greater than 1 atmosphere at 0° C.

Preferably, the O₂ partial pressure in the vagina 90 minutes aftertampon insertion is less than about 50 mm Hg. The O₂ partial pressureproduced in the vagina by insertion of conventional tampons usingconventional inserters is disclosed by Wagner et al., Am. J. Obstet.Gynecol., 148, 147-150 (1984).

The telescoping tube type inserter may have inwardly tapering flexiblesegments at the leading end to form a normally closed, smooth, openable,leading end. The tampon 20 is resiliently compacted and is maintained inthat condition before and during insertion by placing it in the tubularinserter.

An assembly for sterile insertion into a vagina may be utilized whichcomprises a semirigid insertion tube, containing the tampon, telescopedinside a semirigid guide tube having a flexible sheath secured to itsinner end which is tucked back into the insertion tube. The user alignsthe assembly with the vaginal canal and plunges the insertion tubeinward of the guide tube so that a portion of the insertion tube entersthe vagina while the flexible sheath extends to sheathe the portion ofthe insertion tube within the vagina. Thereafter, a plunger is used toeject the tampon from the insertion tube to locate the tampon in thevagina beyond the constricting muscles. The sheath may inhibit O₂ andCO₂ from migrating into the tampon during insertion.

A flexible enclosure may be used to protect the combination tampon andinserter 10 from contamination. More particularly, the flexibleenclosure seals the combination tampon and inserter 10 to prevent O₂ andCO₂ from migrating into the tampon before the tampon is inserted (i.e.,during storage of the combination tampon and inserter 10).

The forward end of the tampon 20 may be flared open to a funnelconfiguration by the inserter during insertion. In such an inserter, amembrane is secured to the perimeter wall of the forward end of thetampon device and extends around to the forward end of the insertioncylinder where it is secured in a fused area. The membrane is used toflare the end of the tampon but also can act as a seal over the end ofthe tampon to inhibit O₂ and CO₂ from migrating into the tampon prior toinsertion.

Conventional tampons are generally compatible with the present inventionand some representative tampons are discussed below. The tampon mayinclude cotton fibers, rayon fibers, or other materials suitable fortampons. The tampon body may be bulb-shaped. Alternatively, the tamponmay have a rounder geometric shape or other tapered end to facilitateentry into the body.

The tampon may have a container on its interior for holding extramedicant. The container can release the medicants during rupture whichmay occur during insertion.

Additionally or alternatively, the tampon may be fully sealed to preventatmospheric O₂ and CO₂ from migrating into the tampon.

The tampon may be compressed in a capsule prior to insertion. Thebearing capsule may be prepared from a variety of non-toxic, solublefilm-forming materials, such as gelatin. Foam is compressed and insertedinto the capsule in the compressed state. The capsule is preferably madeof a material that readily dissolves upon contact with moisture. Whenthe capsule is inserted into the vagina, the capsule dissolves and thefoam can rapidly expand to contact the vaginal periphery. The capsulemay inhibit O₂ and CO₂ from migrating into the tampon.

The inserter may be covered with a gas-impervious laminate film bag orthe inserter may be made out of laminated metal foil. The laminate filmbag and the laminated metal foil reduce the contamination of the tampon20 with environmental O₂ during storage and preferably have a permeationcoefficient for nitrogen of less than about 3×10⁻⁹ (cm³ mm)/(sec cm² cmHg) and a permeation coefficient for oxygen less than about 1.5×10⁻⁹(cm³ mm)/(sec cm² cm Hg).

According to another embodiment of the invention, a seal 90 is locatedat the rear end of the plunger 30 so that the inserter can maintain apositive pressure of a biocompatible gas. The head pressure inside thetampon inserter should be greater than 1 atmosphere, preferably greaterthan 1.05 atmospheres, and more preferably greater than 1.1 atmospheres.The pressure inside the tampon inserter should not be too great,otherwise discomfort to the wearer may result when the seal is ruptured.Suitable gases include, but are not limited to, nitrogen (preferred),neon, argon, helium, fluorinated hydrocarbons, and other biocompatiblegases having a vapor pressure of greater than 1 atmosphere at 0° C.Carbon dioxide is not suitable because its presence may enhance TSStoxin production.

To maintain a positive pressure of a biocompatible gas, a seal at theforward end of the inserter may be used to ensure that the biocompatiblegas does not escape into atmosphere. The tampon 20 is thus sealed in theinserter. The seal can be made by providing an end cap 120 on theinserter which is preferably integral with the cylindrical sidewalls ofthe inserter. The end cap 120 of the inserter may have radial lines ofweakness which rupture when the plunger 30 is depressed. A tapered endcap 120 is preferred for ease of insertion.

Another embodiment, shown in FIG. 3, has a vessel 130 disposed betweenthe tampon 20 and the plunger 30. The vessel 130 is filled withpressurized biocompatible gas such as nitrogen, argon, helium, neon,fluorinated hydrocarbons, and other suitable biocompatible gases havinga vapor pressure of greater than 1 atmosphere at 0° C. During insertion,when the plunger 30 is depressed, the vessel 130 bursts as the vessel130 is compressed between the plunger 30 and the tampon 20. Thebiocompatible gas released from the vessel 130 inhibits O₂ and CO₂ frommigrating into the tampon 20 during insertion.

In order to maintain the requisite internal pressure and to reducecontamination of the tampon 20 with environmental O₂ during storage, anymaterial used would preferably have a permeation coefficient fornitrogen of less than about 3×10⁻⁹ (cm³ mm)/(sec cm² cm Hg) and apermeation coefficient for oxygen less than about 1.5×10⁻⁹ (cm³ mm)/(seccm² cm Hg). Materials suitable for forming the inserter include highdensity polyethylene, nylon 6, polyethylene terephthalate,ethylene-vinylalcohol copolymer, and polyvinylidine chloride. Nylon 6,PET, and polyvinylidine chloride are the preferred materials. Alsosuitable would be a laminate having a metal foil layer or the like.

According to another embodiment of the invention, an effective amount ofan antioxidant (also referred to as an oxygen scavenger) can beincorporated into the inserter. The antioxidant will combine with anyresidual oxygen that is not removed when the inserter is filled with abiocompatible gas and sealed. Furthermore, the antioxidant will combinewith any oxygen that may later diffuse into the inserter. Suitableantioxidant materials include those having a conjugated double bond suchas tocopherals (including vitamin E, which is preferred), stericallyhindered phenols (BHT), those materials which are readily oxidized, suchas sulfites, ascorbic acid, ferrous sulfate, and stannous chloride, andthose which can absorb oxygen (e.g., by chemisorption), such asporphyrins.

If liquid antioxidants such as vitamin E are used, such liquids could beimmobilized on the inside surface of the inserter. Blending the vitaminE with the resin used to produce the inserter would be an alternativemeans of making it available to protect against O₂.

According to still another embodiment, an oxygen absorber can beincorporated into the inserter material. Suitable thermoplastic resinsinclude olefins, polyesters and polyamides. Suitable oxygen absorbingagents include metallic type agents having a metal such as iron as amain component and organic type agents having an organic compound suchas ascorbic acid as a main component. Those and other suitablethermoplastic resins and oxygen absorbers are disclosed in EuropeanPatent Application EP 0 720 821 A2, the disclosure of which is herebyincorporated by reference.

According to another embodiment of the invention, the pad having areduced O₂ level can also comprise an antioxidant which will combinewith or scavenge any residual oxygen molecules not removed from thetampon pad or otherwise replaced by other gases. Additionally, anantioxidant will combine with or scavenge any O₂ molecules presentduring storage or which diffuse into the tampon during storage or whichmay infiltrate into a pad during its insertion into the body. Suitableantioxidants include those having a conjugated double bond, stericallyhindered phenols, porphyrins, ascorbic acid, vitamin E, ferrous sulfate,stannous chloride or any of a variety of well known safe antioxidants.Further, because CO₂ has an effect in promoting the production of toxicshock syndrome exotoxin the pads of the invention may further compriseCO₂ scavengers such as water to scavenge any CO₂ which is present orinfiltrates into the pad.

As a further aspect of the present invention, bactericides may beincorporated into the pads with those bactericides which are specificfor Staphylococcus aureus being preferred. Means such as buffer agentsmay also be incorporated into the pads so as to maintain the pH of thefluids absorbed in the tampon in the range of about 2.5 to 5.5.

Various methods well within the skill in the art may be used to reducethe level of O₂ in the tampon of the invention. According to suchmethods, the absorptive pads may be produced and packaged (i.e., sealedin the inserter) under reduced pressure so as to minimize the level ofO₂ and CO₂ present in the interstices of the pad. Alternatively, or inthe combination with producing and packaging the products under reducedpressure, atmospheric air containing O₂ and CO₂ may be replaced with abiocompatible gas such as nitrogen (N₂), neon, helium, argon, afluorinated hydrocarbon, or another suitable biocompatible gas that hasa vapor pressure of greater than 1 atmosphere at 0° C. and which doesnot promote the production of toxic shock syndrome exotoxin. The tamponitself (while inside the inserter) or the tampon/inserter combinationmay be sealed in a wrap made from plastic, paraffin or other materialwhich prevents O₂ and CO₂ infiltration. The wrap preferably has apermeation coefficient for nitrogen of less than about 3×10⁻⁹ (cm³mm)/(sec cm² cm Hg) and a permeation coefficient for oxygen less thanabout 1.5×10⁻⁹ (cm³ mm)/(sec cm² cm Hg). The wrap helps maintainbiocompatible gas overpressure within the tampon and inserter. Thetampon of the present invention may also comprise an overwrap such asthe overwrap disclosed in Baier, et al., U.S. Pat. No. 3,902,493.

According to still another method, production and packaging of thetampons of the invention may be carried out under conditions whereinatmospheric air is replaced with a biocompatible gas such as nitrogen,neon, argon, helium, a fluorinated hydrocarbon, or another suitable gashaving a vapor pressure of greater than 1 atmosphere at 0° C. The tamponis preferably packaged or sealed in the inserter in the presence ofbiocompatible gases at an elevated positive pressure such that O₂ andCO₂ infiltration into the product is minimized.

According to still another embodiment of the invention, O₂ scavengerscan be incorporated into the tampons having reduced O₂ and CO₂ levelsduring the manufacturing process. The scavengers will act to scavengeresidual oxygen molecules not removed from the pads or otherwisereplaced by other gases. Suitable oxygen scavenging materials includeascorbic acid, vitamin E, ferrous sulfate, stannous chloride or any of avariety of well known, safe oxygen scavengers. Such scavengers may beincorporated into the absorptive pads of the invention at levels rangingfrom about 10 mg to about 500 mg. Further, the oxygen scavengers can beadded to the absorptive pad during the manufacturing process accordingto well known methods such as by applying solutions of the scavengers tothe pads and drying the pads. Alternatively, the scavengers can be addedin solutions of water or tocopherol (Vitamin E) which act as lubricants.Where the oxygen scavengers are added to the pads the scavenging effectcan occur both during storage of the pad as well as after insertion intothe body. Alternatively, the oxygen scavengers can be incorporated tothe packaging or inserter to inhibit oxygen migration into the productduring storage.

Because CO₂ may stimulate toxic shock exotoxin production, CO₂scavengers can also be added to the absorptive pad or packaging toscavenge CO₂. According to one embodiment of the invention, water itselfis added to the pad as a scavenger for CO₂ which can then dissolve intothe water forming carbonic acid. An effective amount of CO₂ scavengersmay be incorporated into the inserter.

It is anticipated that numerous variations and modifications of theembodiments described above will occur to those of ordinary skill in theart when apprised of the teachings of the present specification.Accordingly, only such limitations as appear in the appended claimsshould be placed thereon.

What is claimed is:
 1. A package for a combination catamenial tampon andinserter, wherein said package comprises a laminate film bag having apermeation coefficient for nitrogen of less than about 3×10⁻⁹ (cm³mm)/(sec cm² cm Hg) and a permeation coefficient for oxygen less thanabout 1.5×10⁻⁹ (cm³ mm)/(sec cm² cm Hg), said bag being pressurized to apressure greater than one atmosphere using a first biocompatible gasprior to sealing said catamenial tampon and inserter therein.
 2. Apackage according to claim 1 wherein said first biocompatible gas isselected from the group consisting of nitrogen, neon, argon, helium, andfluorinated hydrocarbons having a vapor pressure greater than 1atmosphere at 0° C.
 3. A package according to claim 1 wherein saidinserter is pressurized to a pressure greater than one atmosphere usinga second biocompatible gas before said catamenial tampon is sealedtherein.
 4. A package according to claim 3 wherein said secondbiocompatible gas is selected from the group consisting of nitrogen,neon, argon, helium, and fluorinated hydrocarbons having a vaporpressure greater than 1 atmosphere at 0° C.